Study of Efficacy on NT-proBNP of Recombinant Human Neuregulin-1 in Chronic Heart Failure Patients
NCT ID: NCT01439789
Last Updated: 2017-12-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
TERMINATED
PHASE3
146 participants
INTERVENTIONAL
2011-06-30
2012-06-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
rhNRG-1
Recombinant human neuregulin-1 administration in addition to basic therapy of chronic heart failure
rhNRG-1
day1\~day10:0.6ug/kg/day,10hours per day for vein infusion
Plaebo
Excipient placebo in addition to basic therapy of chronic heart failure
Placebo
day1\~day10:0.6ug/kg/day,10hours per day for vein infusion
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
rhNRG-1
day1\~day10:0.6ug/kg/day,10hours per day for vein infusion
Placebo
day1\~day10:0.6ug/kg/day,10hours per day for vein infusion
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Left ventricular ejection fraction (LVEF)≤40% (ECHO).
3. NYNA functional class II\~III.
4. Definitely diagnosed with chronic systolic heart failure (including medical records, symptoms and physical signs)and clinical symptom is steadily in the latest 1 month.
5. Receiving standard basic treatment of heart failure, has reached the objective dosage or the highest tolerated dosage for at least 1 month, or the dosage has not been changed for at least 1 month.
6. Capable of signing the informed consent form.
Exclusion Criteria
2. Ischemic heart failure without recanalization or with recanalization in recent six months.
3. Cardiac surgery or cerebrovascular accident within recent six months.
4. Preparing for heart transplantation or has received CRT treatment.
5. Serious hepatic or renal dysfunction caused by organic pathological changes (Cr\>2.0mg/dl, AST or ALT 5 times above the normal upper limit).
6. Patients need mechanical ventilation.
7. Systolic blood pressure \<90mmHg or \>160mmHg.
8. Patients with acute hemodynamic disorder or decompensation in the last 1 month.
9. Serious ventricular arrhythmia (multi-morphological premature ventricular contraction, frequent paroxysmal ventricular tachycardia).
10. Serum potassium \<3.2 mmol/L or \>5.5 mmol/L.
11. Pregnant or plan to pregnant.
12. Unmarried or married but not procreated women at child-bearing age.
13. Subject with a life expectancy less than 6 months as assessed by the investigator.
14. Patients who participated in any clinical trial in the recent three months.
15. History of any malignancy or suffering from cancer,or biopsy proven pre-malignant condition (eg DICS or cervical atypia).
16. Evidence (physical examination,CXR,ECHO or other tests) shows some active malignancy or adenoidal hypertrophy or neoplasm has effect on heart function or endocrine system, eg pheochromocytoma or hyperthyroidism.
17. Judging by the investigator, the patients could not complete the study or adhere to the study requirements (due to the management reasons or others).
18 Years
75 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Zensun Sci. & Tech. Co., Ltd.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Runlin Gao, MD, Ph.D
Role: PRINCIPAL_INVESTIGATOR
Cardiovascular Institute and Fuwai Hospital
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Cardiovascular Institute and Fuwai Hospital
Beijing, Beijing Municipality, China
Bethune Peace Hospital
Shijiazhuang, Hebei, China
Teda International Cardiovascular Hospital
Tianjin, Hebei, China
Daqing Oilfield General Hospital
Daqing, Heilongjiang, China
The First Hospital of Harbin Medical University
Haerbin, Heilongjiang, China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
The Second Xiangya Hospital of Central South University
Changsha, Hunan, China
Sichuan Provincial People's Hospital
Chengdu, Jiangsu, China
The Second Hospital affiliated to Suzhou University
Suzhou, Jiangsu, China
North Jiangsu People's Hospital
Yangzhou, Jiangsu, China
The Affiliate Hospital of Jiangsu University
Zhenjiang, Jiangsu, China
The Second Hospital of Jilin University
Changchun, Jilin, China
The First Hospital affiliated to Dalian Medical University
Dalian, Liaoning, China
The first affiliated hospital of Liaoning medical college
Jinzhou, Liaoning, China
Liaoning Provincial People's Hospital
Shenyang, Liaoning, China
Shengjing Hospital of China Medical University
Shenyang, Liaoning, China
Qilu Hospital of Shandong University
Jinan, Shandong, China
Shanghai First People's Hospital
Shanghai, Shanghai Municipality, China
Shanghai Sixth People's Hospital
Shanghai, Shanghai Municipality, China
The Xinqiao Hospital of Third Military Medical University
Chongqing, Sichuan, China
Kunming General Hospital of Chengdu Military Region
Kunming, Yunnan, China
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
ZS-01-304
Identifier Type: -
Identifier Source: org_study_id